A Cohort Study of Mobile Capsule Gastroscopy for Gastric Pathologies Screening

NCT ID: NCT07032961

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-24
• Study Completion Date: 2030-10-31

Brief Summary

The goal of this is to learn about the effectiveness and feasibility of a novel AI- assisted Mobile Capsule Gastroscopy (MCG) system for detecting gastric pathologies in elderly and high-risk populations.

The main question it aims to answer is:

Can MCG effectively detect gastric pathologies, including common gastric diseases, gastric cancer, and precancerous lesions, in elderly and high-risk individuals at community health centers?

Participants will:

Epidemiological, diagnostic, and post-MCG follow-up data generated during participants' involvement in the gastric pathologies public screening program will be collected.

Detailed Description

Gastric diseases-including atrophic gastritis, gastric polyps, peptic ulcers, submucosal lesions, gastric cancer, and precancerous conditions-have become a major global public health challenge. In China, the prevalence of gastric ulcers is as high as 17.2%, significantly higher than that in Western countries (4.1%) [1]. Gastric cancer also ranks among the top globally in both incidence and mortality, with approximately 400,000 new cases and over 300,000 deaths each year [2-3]. Notably, around 80% of patients are diagnosed at an advanced stage, and the 5-year survival rate is less than 30% [4]. Studies have shown that early gastric cancer, if detected and treated promptly, can achieve a 5-year survival rate of over 90% [5]. Moreover, if benign conditions such as atrophic gastritis and peptic ulcers are not treated in time, they may progress into precancerous lesions or even malignancies [6]. Therefore, early screening and accurate diagnosis are key to reducing the disease burden of gastric disorders.

Although esophagogastroduodenoscopy (EGD) is considered the gold standard for gastric disease screening [7-8], its invasive nature, associated patient discomfort, and reliance on skilled endoscopists and specialized equipment limit its accessibility. In China, the scarcity of endoscopic resources in primary care settings, combined with low patient compliance, further restricts screening coverage and increases the risk of missed diagnoses [9-10].

In recent years, capsule endoscopy has emerged as a valuable complementary tool for gastrointestinal disease screening due to its non-invasive and user-friendly nature [6,7]. Among its modalities, magnetically controlled capsule gastroscopy (MCCG) provides comprehensive gastric visualization, with reported sensitivity and specificity of 90% and 92%, respectively, for common gastric lesions. However, its reliance on expensive magnetic navigation systems and trained operators limits its widespread adoption in community-based screening programs [8].

To address these limitations, a novel mobile-controlled capsule gastroscopy (MCG) system being more accessible and not requiring costly external magnetic control was developed. It consists only of a disposable capsule and a wireless portable receiver. Participants can complete the examination independently in community health centers or at home by following video instructions via a smartphone app and adjusting their body positions to guide the capsule. An AI algorithm ensures complete gastric coverage in real time. The video can be viewed directly on the smartphone and transmitted to the cloud for remote diagnosis. The MCG system is non-invasive, user-friendly, and compatible with remote diagnosis, making it well suited for gastric disease screening in community health centers. Compared with MCCG, MCG enables fully autonomous operation without magnetic navigation, substantially reducing technical complexity and healthcare costs. However, its diagnostic accuracy and real-world feasibility in community-based populations have yet to be validated through prospective studies.

In 2025, the Guangzhou Municipal Health Commission issued the 'Gastric Pathologies Screening Programme for the Elderly and High Risk Groups in Guangzhou Municipality'. Organized by the Commission and led by Southern Medical University Nanfang Hospital, with participation from Guangzhou First People's Hospital, The Second Affiliated Hospital of Guangzhou Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine, and others, the program will conduct screening and surveillance of 10,000 elderly and high-risk individuals in community health centers across Guangzhou.

This prospective cohort study will collect epidemiological data, examination results, follow-up outcomes, and other relevant information from the screening program. The primary endpoint is the detection rate of gastric pathologies, including common conditions (such as atrophic gastritis, gastric ulcers, and submucosal tumors), gastric cancer, and precancerous lesions. The operational feasibility, safety, and acceptability of the MCG system in primary care settings will also be assessed. Findings are expected to provide scientific evidence to support the optimization of gastric disease prevention and control strategies at the municipal level.

1. Baseline Period

1. Record demographic data: gender, age

2. Record medical history and physical examination: including vital signs, anthropometric data (height and weight), comprehensive systemic assessment, history of smoking and alcohol use, Helicobacter pylori infection status, prior gastric pathologies, family history of gastric cancer, and mode of transportation to the clinic.

2. Diagnostic & Therapeutic Procedures

1. Record laboratory tests (if available), including complete blood count, stool analysis, prothrombin time, and the ¹³C/¹⁴C urea breath test.

2. Record the results of the MCG, the anatomical coverage of gastric regions, the rate of device failure and the overall image quality of the examination.

3. Record findings and therapeutic interventions from esophagogastroduodenoscopy (EGD) and histopathological biopsy results (if available).

3. Follow-up prognostic data

1. Record short-term follow-up data, including capsule endoscopy expulsion status, adverse events, referral outcomes, subsequent treatment, and patient compliance.

2. Record long-term follow-up data, including gastric pathologies incidence and survival rates of project participants.

3.1 Short-term follow-up will be conducted on Days 1, 3, and 14 following MCG.

1. Participants are instructed to inspect stool for capsule excretion and report the time of passage. If the capsule is not passed within 72 hours and gastrointestinal symptoms occur (e.g., constipation, abdominal pain), the research team will arrange clinical evaluation. Capsule retention will be confirmed via abdominal X-ray or CT. Management may include prokinetic therapy or surgical retrieval as needed; the study will be discontinued post-retrieval in such cases.

2. All participants will receive a report summarizing the findings of the MCG examination. Researchers from community centers will follow up with individuals whose reports indicate significant gastric abnormalities to facilitate further medical management. Additionally, the overall study findings will be disseminated through publication in a peer-reviewed scientific journal.

3.2 Long-term follow-up will be conducted annually for a duration of five years through telephone interviews and/or routine monitoring at community health centers.

Conditions

Gastritis; Gastric Dysplasia; Gastric Ulcer; Gastric Cancer; Gastric Mass

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Enrolment Group

The enrolment group includes all subjects who will undergo MCG examination in the 'Gastric pathologies Screening Programme for the Elderly and High Risk Groups in Guangzhou Municipality'.

Collect epidemiological, diagnostic, and follow-up data after MCG examination.

Intervention Type: OTHER

MCG System: GICE-1000 Manufacturer: Guangzhou Side Medical Technology Co., Ltd.

Interventions

Collect epidemiological, diagnostic, and follow-up data after MCG examination.

MCG System: GICE-1000 Manufacturer: Guangzhou Side Medical Technology Co., Ltd.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1.Provision of written informed consent; 2.Participants of the 'Gastric Pathologies Screening Programme for the Elderly and High Risk Groups in Guangzhou Municipality', the following are the criteria for inclusion in this public welfare programme:

1. Elderly cohort: Permanent residents of Guangzhou aged ≥60 years who have not undergone specialized gastric disease screening in the past three years;

2. Or high-risk cohort: Individuals aged ≥45 years who meet at least one of the following risk criteria:

1. History of Helicobacter pylori infection (positive ¹³C/¹⁴C urea breath test);

2. Prior diagnosis of chronic atrophic gastritis, gastric ulcer, neoplastic gastric polyps, hypertrophic gastritis, or pernicious anemia;

3. Family history of gastric cancer (first-degree relative with a confirmed diagnosis);

4. Long-term high-salt diet, smoking history (≥20 pack-years), or heavy alcohol consumption (100 mL of distilled spirits/day).

Exclusion Criteria

1. Not considered by the investigator to be suitable for participation in this study.

(1)Known allergy to medical polymer materials; (2)Psychiatric disorders that interfere with procedural cooperation; (3)Pregnancy or lactation; (4)Severe systemic comorbidities (e.g., cardiovascular, respiratory, neurological diseases) affecting examination tolerance; (5)Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or gastrointestinal diverticulosis; (6)Known or suspected gastrointestinal malformations, obstructions, strictures, or fistulas; (7)Clinically significant dysphagia; (8)Acute abdominal symptoms (e.g., pain, vomiting, suspected bowel obstruction, or severe constipation); (9)History of major gastrointestinal surgery (e.g., esophagogastrostomy, gastrojejunostomy); (10)Physical debilitation precludes postural changes or concurrent severe illness; (11)Medically ineligible for abdominal procedures or refusal to undergo them; (12)Deemed unsuitable for MCG by the investigator; (13)Refusal to provide informed consent; (14)Any other condition judged by the investigator to make the individual unsuitable for study participation.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou First People's Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaobei Luo

Role: CONTACT

luoxiaobei63@126.com

+86 17688881428

Facility Contacts

Xiaobei Dr. Luo

Role: primary

luoxiaobei63@126.com

+86 176 8888 1428

Other Identifiers

NFEC-2025-276

Identifier Type: -

Identifier Source: org_study_id